Search Results for PMA

Showing 1 – 25  of 43

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo

Navigating the Medical Device User Fee Act (MDUFA) By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 25 May 2017

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Features, US, CDRH, Medical Devices, Submission and registration

Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees

Medical Device Performance Goals: FDA Offers a Quarterly Update By Zachary Brennan - Published 09 December 2016

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent

Almost 90% of PMA Applicants Received Major Deficiency Letter on First FDA Review Cycle in 2016 By Zachary Brennan - Published 09 September 2016

New data from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) show that through the first six months of 2016, 89% of premarket approval applications (PMAs) received a major deficiency letter in the first review cycle.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, PMA approvals, major deficiency letters

FDA to Require PMAs for Two Types of Hip Replacement Devices By Zachary Brennan - Published 17 February 2016

The US Food and Drug Administration (FDA) on Wednesday announced the issuance of a final order requiring manufacturers to submit a premarket approval (PMA) application for two types of metal on metal (MoM) total hip replacement devices.

Categories: News, US, CDRH, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: metal-on-metal hip implants, PMA, medical device, Class III

FDA Sees Record-High PMA Approval Rate for 2015 By Zachary Brennan - Published 11 November 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process.

Categories: News, US, CDRH, Audit, Compliance, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PMA, 510(k), PMA approvals, FDA statistics, Food and Drug Administration, FDA, CDRH

FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes By Zachary Brennan - Published 20 October 2015

Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval application (PMA) supplement will want to consult with draft guidance from the US Food and Drug Administration (FDA) released Tuesday.

Categories: News, US, FDA, Compliance, Due Diligence, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: PMA, FDA, premarket approval, medical device manufacturing, FDA draft guidance

FDA Identifies More Than 20 PMA Devices Eligible for Reclassification to Class II By Stewart Eisenhart, Emergo - Published 01 May 2015

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes.

Categories: News, US, CDRH, Medical Devices

Tags: Emergo, PMA, Reclassification

High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy Published 02 February 2015

The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Submission and registration

Tags: AED, Automated External Defibrillator, PMA, 510(k), Regulation, Final Rule

FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds By Alexander Gaffney, RAC - Published 23 October 2014

A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: PMA, 510(k), De Novo, Review Times, Review Cohort, Medical Device Approvals

FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon By Alexander Gaffney, RAC - Published 20 August 2014

The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, a market intelligence firm.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: PMA, HDE, Medical Device Approvals, CDRH Approvals

FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products By Alexander Gaffney, RAC - Published 29 April 2014

Categories: US, FDA, CDRH

Tags: Device Reclassification, POP, Transvaginal Mesh, Class II, Latest News, Class III, PMA, medical device

FDA Launches Long-Awaited Expedited Approval Program Aimed at High-Need Devices By Alexander Gaffney, RAC - Published 22 April 2014

Categories: US, FDA, CDRH

Tags: EAP Device, EAP Designation, Expedited Access PMA, EAP, Expedited Approval, Latest News, PMA, draft guidance, guidance, medical device

CDRH, CBER Finalize Medical Device Review Communication Guidance By Alexander Gaffney, RAC - Published 03 April 2014

Categories: US, FDA, CBER, CDRH

Tags: Substantive Interactions, Acceptance Review, Interactive Review, BLA, Communication, Latest News, 510(k), PMA, guidance

FDA Unveils Strengthened Medical Device Reporting Database With New Features By Alexander Gaffney, RF News Editor - Published 16 December 2013

Categories: US, FDA, CDRH

Tags: Recall, 510(k), PMA, medical device

FDA Finalizes Extensive Guidance on Pivotal Trials for Medical Devices By Alexander Gaffney, RF News Editor - Published 07 November 2013

Categories: US, FDA

Tags: De Novo, 510(k), PMA, guidance, clinical trials, medical device

CDRH Says Dozens of Applications Affected During Shutdown, and Residual Delays Likely By Alexander Gaffney, RF News Editor - Published 25 October 2013

Categories: US, FDA, CDRH

Tags: User Fees, MDUFA, Latest News, 510(k), PMA

Ambiguity from FDA Stunts Growth in the US, While Innovation Flourishes in Europe By Christopher J.P. Velis - Published 23 July 2013

Inconsistency and ambiguity in the US Food and Drug Administration's (FDA) regulatory process have created an environment of uncertainty in the medtech industry, stunting investment and slowing critical scientific advances. As a result of this confusion, investors are shy to support breakthroughs; the US risks losing its edge-and its market share-to regions with more fluid, predictable approvals.

Categories: US, FDA

Tags: Perspective, 510(k), PMA, approval, innovation, EU, medical device, regulatory

FDA Finalizes Guidance on Priority Review Process for Medical Devices By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US, FDA

Tags: PDP, BLA, 510(k), PMA

FDA Data Show the Worst is Over for 510(k), PMA Submissions By Alexander Gaffney, RF News Editor - Published 17 May 2013

Categories: US, FDA

Tags: Jeffery Shuren, 510(k), PMA

Prominent Consumer Group Petitions FDA for Changes to Device Approval System By Alexander Gaffney, RF News Editor - Published 19 April 2013

Categories: US, FDA

Tags: Consumers Union, 510(k), PMA, medical device

New FDA Guidance Clarifies Process for Submission of Device User Fees By Alexander Gaffney, RF News Editor - Published 04 April 2013

Categories: US, FDA

Tags: FDASIA, BLA, User Fee, MDUFA, Latest News, PMA, guidance, medical device

US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing By Alexander Gaffney, RF News Editor - Published 21 February 2013

Categories: FDA, CDRH

Tags: Allergan, Breast Implant, PMA, approval

FDA Looks to Finally Implement Pediatric Data Requirements for Most Device Submissions By Alexander Gaffney, RF News Editor - Published 19 February 2013

Categories: FDA

Tags: HDE, PMA, medical device